By: Angela Mulholland, News

Date: Sun. Jun. 21 2009 6:58 AM ET

Oprah takes them. So does Dr. Phil's wife, Robin McGraw. Suzanne Somers rubs them into her chest and injects them into places where the sun don't shine.

They're called bio-identicals and many say they just might be the fountain of youth.

Bio-identicals are being touted by many as the answer for women who want to relieve their menopause symptoms, reverse aging and even prevent heart disease and cancer.

But others say the medications are nothing more than snake oil. The U.S. FDA (Federal Drug Administration) has even become so concerned about the bio-identicals fuss, it felt compelled to issue a statement warning women that there is no proof that bio-identical creams, gels and suppositories are either safe or effective.

That might not matter, now that the "Oprah effect" appears to have kicked in. After Somers calling bio-identicals "the juice of youth," Oprah featured the former TV sitcom star on her talk show and then waxed poetic on the wonders of bio-identicals in a recent issue of her 'O' Magazine.

"After one day on bio-identical estrogen, I felt the veil lift," Winfrey wrote. "After three days, the sky was bluer, my brain was no longer fuzzy, my memory was sharper. I was literally singing and had a skip in my step."

What had Oprah singing is the estrogen and other hormones found in bio-identical formulations. The hormones are derived from plants (mostly soy and yam oils) and because their molecular structure exactly matches those of human hormones, proponents say they are more "natural" than conventional hormone therapy.

'Correcting hormones is not playing God'

Dr. Andrew Wojcicki, a trained internist is one of a handful of doctors bucking warnings from the FDA and advisories from the Society of Obstetricians and Gynaecologists of Canada (SOGC) about bio-identicals. He says women come from all over to his Vivian Medical Spa in Mount Albert, Ont. for his expertise on hormones.

"We have found that bio-identical hormone replacement is very effective," he told in a phone interview. "Patients say they are sleeping better, they have higher energy, their mood swings and hot flashes and other menopause symptoms are gone."

When patients come to him, Wojcicki records their symptoms and assesses their hormone levels with blood and saliva tests. He then decides which hormones need "correcting," and prescribes individualized bio-identical creams, oils and even injections.

Restoring hormones to youthful levels cannot only relieve menopause, he said, it can prevent the diseases that accompany aging and extend life expectancy.

While he knows that mainstream medicine has not caught up with him and other doctors who prescribe bio-identicals, Wojcicki said he is not a quack.

"We are medical doctors," he said. "Correcting hormones is not playing God. It's real science and real medicine."

"It's a new science, it's still evolving. But I have no doubt in five or 10 years, bio-identicals will be part of main core of preventative and mainstream medicine."

'No credible scientific evidence'

Wojcicki said there have been dozens of reliable studies on bio-identicals over the last 25 years that have shown their safety. But the FDA disagrees.

"The FDA is not aware of any credible scientific evidence to support claims made regarding the safety and effectiveness of compounded 'BHRT' drugs," the agency said in a 2008 statement to consumers, entitled "Bio-identicals: Sorting Myths from Facts."

The SOGC and the American College of Obstetricians and Gynecologists (ACOG) have also issued warnings to caution women that there are no long-term studies on bio-identical safety.

Pharmacist Claudia McKeen, the owner of the Glebe Apothecary in Ottawa, who regularly prepares bio-identical hormone formulations, said there have been plenty of studies on bio-identicals, but they have not been the kind of studies that agencies like the FDA want to see: placebo-controlled, double-blinded, randomized trials.

"Those kinds of studies cost a lot of money," she said. "Research is driven by money and money comes from pharmaceutical companies. And the pharmaceutical industry is very much against us."

David Garshowitz, the owner of York Downs Pharmacy in Toronto, who also compounds bio-identical hormone formulations, agreed with that assessment. He said because each bio-identical product is unique and can't be mass-produced, pharmaceutical companies are not funding studies.

"When you get the raw ingredients from natural plants, these products cannot be patented. So pharmaceutical companies are not going to do a study on something on which they can't get a patent," he said.

Products can't be regulated

It's precisely that hand-made aspect of bio-identicals that worries the FDA. The agency notes that because the medications are put together by a pharmacist, they cannot be regulated, nor can they be evaluated for efficacy.

"Pharmacies that compound these 'BHRT' drugs may not follow good drug manufacturing requirements that apply to commercial drug manufacturers," the agency warns. "It is unknown whether these mixtures, which are not FDA-approved, are properly absorbed or provide the appropriate levels of hormones needed in the body."

McKeen dismissed that concern. "It's not like we're slapping things together in a kitchen sink. We're health professionals," she asserted.

"The FDA says they can't regulate it so therefore they can't endorse it. Are they going to say that about the dermatology preparations -- for example the 3 per cent hydrocortisone in Dermabase -- that we compound all the time, too?"

Just because a product is FDA-approved doesn't mean it's safe, Wojcicki noted, pointing to the example of Vioxx, which was pulled from the market after serious side effects emerged once the medication became widely used by consumers.

Wojcicki said he studies all the literature on bio-identicals and knows of none that have found any serious safety worries or links to cancer, like those uncovered with conventional HRT.

"We have found that bio-identical hormone replacement is extremely safe," he says, "Bio-identicals have never been linked by any stretch of the imagination to any increased risk of cancer -- to the contrary, they can prevent cancer and many other diseases."

Gynecologist Dr. Jenny Blake, who co-wrote the Menopause and Osteoporosis Update 2009 for the SOGC, worries about such assertions. She said there is simply not enough evidence to say whether bio-identical HRT is any safer than conventional HRT, particularly over the long term.

"To find the safety issues with HRT, we had to look at more than 16,000 women. I could have said that HRT was safe if I just based it on my practice. Because I never saw any problems," she said.

She pointed out that plant-derived, bio-identical estrogen is already commercially available in several brand-name prescription drugs that are Health Canada-approved, such as Estrace and Estrogel.

But bio-identical proponents say commercial formulations are not the same, because they are one-size-fits-all and can't be tailored to match a woman's changing hormone levels. Blake said that whole concept is flawed.

"We don't measure hormone blood levels because there is no ideal level. In fact, there is no relationship whatsoever between the measurable level of a hormone to whether a woman is actually having symptoms. It's just more complex than that. In involves other brain chemicals and neurotransmitters and other factors," she said.

Placebo effect?

When doctors and pharmacists who prescribe and prepare bio-identical formulations claim that almost all of their patients are satisfied with the medications, Blake wonders about that too.

"When you look at the placebo-controlled studies on any kind of menopause treatment, there is a pretty high placebo response rate too," she said.

"We have seen lots of women who have said that bio-identicals are a waste of time and haven't worked for them. So unless you've done a careful study, you don't know how all your patients are doing; you only see those who are happy."

Nevertheless, Blake doesn't doubt that bio-identicals help to relieve menopausal symptoms in many women. "Estrogen is very effective for this, no matter how you get it."

That's why despite the confusing headlines about HRT in recent years, she says her report concluded that HRT is still a good option for women struggling with menopause.

"The SOGC position is quite clear: women who are looking to manage their symptoms, the conventional low-dose medications are safe if used for short periods up to five years," emphasized Blake.

"Even beyond that, the risks that come over time are, for any individual woman, extremely remote."